Please select one option only for each

Please select one option only for each . Quality System regulations require that a pharmaceutical manufacturer have a policy detailing management and executive responsibilities in the organization’s quality system. (a) True (b) False _____________________________________________________________________ (2) FDA’s guidance from “Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects ” do not establish legally enforceable responsibilities. Instead, guidance’s describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. (a) True (b) False _____________________________________________________________________ (3) FDA 21 CFR 820 FDA covers the quality regulations for computer systems used in the collection and management of data in clinical trials. (a) True (b) False __________________________________________________________________ (4) The core element of GxP quality systems is the use of SOPs. (a) True (b) False __________________________________________________________ (5) Pharmaceutical companies need only implement a Corrective and Preventive Action system when an issue is identified during an FDA inspection. (a) True (b) False __________________________________________________________ (6) Quality Assurance must have regulatory affairs experience (a) True (b) False __________________________________________________________ (7) Biometric authentication for electronic signatures includes indentification and verification. (a) True (b) False _____________________________________________________________________ (8) Manufacturers must use a standards organization that is recognized by the FDA to conduct regular audits to assure the manufacturer’s quality system is in compliance with applicable regulations. (a) True (b) False _____________________________________________________________________ (9) Biometrics used for the identification of individual’s accessing electronic records systems might include: (a) A and C (b) Social Security Number (c) Retinal Scans (d) Fingerprints _____________________________________________________________________ (10) The Major issue with Shrink wrapped off the shelf software is : (a) It many not be beta tested (b) All of the above (c) Quality of the software might be substandard (d) The inherent ability to modify or delete data without a trace _____________________________________________________________________ (11) 21 CFR 11 main purpose is to ensure that electronic records and electronic signatures are trustworthy, reliable, and equivalent to paper records with handwritten signatures. (a) True (b) False _____________________________________________________________________ (12) According to FDA Guidance on IRB responsibilities the IRB must determine whether an investigator is qualified to conduct the trial. Steps an IRB can take to determine investigator qualifications include: (a) Verify Medical License (if applicable) (b) Verify Professional organization (c) All of the above (d) Review the investigator and subinvestigator’s CVs _____________________________________________________________________ (13) In conducting clinical investigations of drugs, including biological products, under 21 CFR part 312 and of medical devices under 21 CFR part 812, the investigator is responsible for: (a) A and B (b) Protecting the rights, safety, and welfare of subjects under the investigator’s care. (c) All of the above (d) Controlling drugs, biological products, and devices under investigation (e) Ensuring that a clinical investigation is conducted according to the signed investigator statement for clinical investigations of drugs, including biological products, or agreement for clinical investigations of medical devices, the investigational plan, and applicable regulations. _____________________________________________________________________ (14) SOPs must include: (a) B and C (b) The individual responsible for administering the SOP (c) All of the above (d) Must describe the purpose of the SOP. (e) The organization’s operation area(s) to which the SOP applies. _____________________________________________________________________ (15) Training Staff : (a) Helps retain staff (b) All of the above (c) Helps motivate staff (d) Cuts down on absenteeism _____________________________________________________________________ (16) when carrying out a facility inspection on quality assurance the inspector should look at the following: (a) B and C (b) Detailed job descriptions (c)Training SOPs (d) Documentation of training session dates and times (e) All of the above _____________________________________________________________________ SCIENCE HEALTH SCIENCE NURSING NUR 4325

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